Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| Sample Type | Blood |
| User | Professional |
| Accuracy | 98.7%(97.5%-99.4%) |
| Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| After-sales Service | Available |
| Key words | Cardiac Troponin I (cTnI)One Step Test with CE certificate Test Device |
| Combo Device | Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette |
| Brand Name | Aichek |
| Model Number | CTI-A01 |
| Certification | CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | Storage | 2℃-30℃ |
| Sample Type | Blood | User | Professional |
| Accuracy | 98.7%(97.5%-99.4%) | Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable | Formats | 25T/box 1T/box |
| After-sales Service | Available | Key words | Cardiac Troponin I (cTnI)One Step Test with CE certificate Test Device |
| Combo Device | Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette | Brand Name | Aichek |
| Model Number | CTI-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | I CTnI Cardiac Troponin T Test Kit ，I CTnI LFT Lateral Flow Test ，Blood LFT Lateral Flow Test | ||
| Product Name | Cardiac Troponin I (cTnI) One Step Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Sensitivity and Specificity
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial cTnI EIA test using clinical specimens. The results show that the sensitivity of the Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is 98.3% and the specificity is 98.8% relative to the leading EIA test.
Troponin I Rapid Test Device vs. EIA
| Method | EIA Test |
Total Results |
||
| Troponin I Rapid Test Device | Results | Positive | Negative | |
| Positive | 113 | 6 | 119 | |
| Negative | 2 | 493 | 495 | |
| Total Results | 115 | 499 | 614 | |
Relative Sensitivity: 98.3%(93.9%-99.8%)* Relative Specificity: 98.8%(97.4%-99.6%)*
Accuracy: 98.7%(97.5%-99.4%)* *95% Confidence Interval
SUMMARY
Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa.1 Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.2 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma.3 cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery.4 Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.5
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-cTnI antibody coated particles and capture reagent to selectively detect cTnI in whole blood, serum or plasma. The minimum detection level is 0.5 ng/mL.
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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